UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049174 |
|---|---|
| Receipt number | R000056011 |
| Scientific Title | Pre close versus post close using suture-mediated closure system for catheter ablation |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2024/07/22 16:57:14 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Pre close versus post close using suture-mediated closure system for catheter ablation
Acronym
Pre close versus post close using suture-mediated closure system for catheter ablation
Scientific Title
Pre close versus post close using suture-mediated closure system for catheter ablation
Scientific Title:Acronym
Pre close versus post close using suture-mediated closure system for catheter ablation
Region
| Japan |
Condition
Condition
tachycardia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
we conducted a prospective randomized study comparing the efficacy and safety of 2 different suture technique for femoral vein access using Perclose ProGlide (PC) suture-mediated closure system.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary efficacy endpoint was rebleeding rate requiring recompression during immobilization, bedrest and after ambulation. The primary safety endpoint is the incidence of major complications related to venous access site closure at 90days.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Pre close
Interventions/Control_2
Post close
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
participants included patients who were over 20 years old who underwent elective, nonemergent, catheter ablation via the common femoral veins using a 6-F to 13F inner diameter introducer sheath, a minimum of 2 and maximum of 4 femoral venous access sites, and a maximum of 3 access sites per leg were enrolled.
Key exclusion criteria
Exclusion criteria included vascular surgery or catheter ablation within the last three months, active systemic or cutaneous infection or inflammation in the vicinity of the groin, any preexisting immunodeficiency disorder, long term use of high dose systemic steroids,
history of bleeding diathesis, coagulopathy, hypercoagulability, or thromboembolic events, platelet count over 100,000 cells per mm, or severe comorbidities with life expectancy 12 months in the opinion of the site investigator. After providing informed consent, patients underwent the appropriate ablation procedure
Target sample size
280
Research contact person
Name of lead principal investigator
| 1st name | Akio |
| Middle name | |
| Last name | Chikata |
Organization
Toyama Prefectural Central Hospital
Division name
Department of Cardiology
Zip code
9308550
Address
2-2-78 Nishi-nagae, Toyama
TEL
076-424-1531
akio.chbikata@gmail.com
Public contact
Name of contact person
| 1st name | Akio |
| Middle name | |
| Last name | Chikata |
Organization
Toyama Prefectural Central Hospital
Division name
Department of Cardiology
Zip code
9308550
Address
2-2-78 Nishi-nagae, Toyama
TEL
076-424-1531
Homepage URL
akio.chbikata@gmail.com
Sponsor or person
Institute
Toyama Prefectural Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Toyama Prefectural Central Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toyama Prefectural Central Hospital
Address
2-2-78 Nishi-nagae, Toyama
Tel
076-424-1531
byoin@esp.pref.toyama.lg.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
The primary efficacy endpoint was the number of rebleeding cases requiring recompression during immobilization and bed rest and after ambulation.
The primary safety endpoint was the incidence of major complications associated with venous access site closure.
Short-term efficacy endpoint and long-term outcomes related to the safety endpoint.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 10 | Day |
Last modified on
| 2024 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056011
